It seems to be widely overlooked that the primary benefit of ISO is derived from the implementation and system maintenance process. The value of certification is greatly overrated unless specific customer requirements exist. If a company goes through the implementation process, objectively evaluates system compliance and appropriate improvements, monitors ongoing system compliance AND adequacy to meet both internal and external needs, and regularly reviews performance metrics to assess any need for further improvement, then that company is achieving the real benefit of ISO quality management systems. A company that actually needs a third-party auditior to evaluate the health of their systems and direct necessary improvements to ensure compliance will likely not reap the same benefits as a company who internally completes an honest evaluation of the health of their QMS and identifies the improvements needed to support their business model. The key here is an honest evaluation intent on making the QMS better serve both the company and any outside entities either purchasing from or supplying to the company. It is far too common that I see companies holding ISO certificates with shallow quality systems that do not truly serve the interests of their customers and therefore from a business sense do not serve the company's best interests. Making meaningless changes to documentation in order to address an audit finding while basic controls like calibration interval adjustments or product traceability are ignored or unnoticed has been an undesirable outcome of the ISO certification boon (very much like teaching to a standardized test in American schools). The documentation alone will never ensure a robust QMS, nor will physical audits performed by 3rd party sources unfamiliar with the inner workings of a company or their systems. The best audits will always be the truly honest internal audits performed for the purpose of QMS evaluation to ensure systems are achieving what they were originally designed or envisioned to do (or adapted when a vision changes). I am a strong proponent of ISO in practical application but I am also a realist about where the true benefits are derived.

I have seen the evolution of quality going from just an inspection function to quality management systems over the past 36 years. I have taken companies from a no documented system to MILQ9858 & ISO9001 compliant systems to certified systems. For a company that has never had a defined system or a poorly defined system, developing and defining a compliant to ISO 9000 series is a good base line for starting the quality journey. The cost of a compliant system is the cost of educating an individual as a Lead Auditor and the time for the staff to write the procedures. If used for improving average product/service quality and reducing total quality cost, ISO 9000 is also a good base line tool. If the goal is to just obtain that "Certificate", then it is a waste of money in the long run. I have had many a discussion with uneducated CEOs on what the ISO 9000 (TS16949) can do for the "Qualtiy Image" of a company. For those companies who have used ISO to truely manage the process as one of the many tools in the quality tool bag, customer satisfaction and profitability has improved. If used for advertising, then the system is doomed. Also, most major industries still have their own requirements in addition to ISO 9000, therefore we have still not realized a single series of standards for worldwide adoption.

Sir, 

I do fully agree with the revolution caused by ISO 9001 series, globally. However, I personally feel that the inbuilt limitations particularly on continual aspect, need further development. On many a occasions, ISO becomes first step and needs to be supplimented by another quality tool. I hope that this limitation may also be bettered by and Intergated ISO 9001 series defining/elaborating the aspect.

Regards

Mahesh M. Mehendale 

Sir, 

I do fully agree with the revolution caused by ISO 9001 series, globally. However, I personally feel that the inbuilt limitations particularly on continual aspect, need further development. On many a occasions, ISO becomes first step and needs to be supplimented by another quality tool. I hope that this limitation may also be bettered by and Intergated ISO 9001 series defining/elaborating the aspect.

Regards

Mahesh M. Mehendale 

Forgive me for this, but an aged Pom would like to raise a few corrections for you Americans to think about.

ISO 9000 was BS 5750 previously, and NATO AQAPs before that. ISO 9001:1987 was almost word for word AQAP-1. The original AQAPs were written and promulgated in 1969 by NATO Committee AC250 founded in 1955. In the UK AQAPs were used by the Ministry of Defence Procurement Executive as the DEFSTAN 05-20 series, Mil 9858 was the equivalent in the US.

The rapid take-up in the UK was unique. The UK remains over-represented per capita in the Mobil Survey. The reason is the 1984 UK National Quality Campaign that was a well-meaning attempt to improve the quality of British exports; those who have ever owned a 1970s British car will understand this perfectly. The Campaign had three main elements. First it set up the first accreditation council (NACCB, now UKAS).  Second, via NACCB, it set up the first certification bodies (LRQA was #001),  Third, and the key, was that government funding was made available through the Dept of Trade & Industry for any British owned company that employed less than 600 people to claim 2/3 the cost of 15 days consultancy if they achieved accredited certification to a BS 5750 standard (Pts 1, 2 or 3).

There were two obvious outcomes.  First 30,000 or more certified companies appeared from nowhere in a few years.  Second and worse, was the emergence of the "15-day quality system" that effectively guaranteed lousy implementation and the appalling professional standards that blight us to this day.  The real disaster here was the almost exclusive use of BS5750:Pt 2 that left out the design clauses in Pt1.  The point missed was that in the commercial sector commercial enterprises always are accountable for the design of their services and products; in fact “ is the design right?” is what concerns most purchasers most.  It followed that accredited certifcation did not challenge this most critical feature in any supplier's system.  Alas, these days, the widespread acceptance of ISO 9001/7.3 exclusions simply continues the felony. 

The other point that is always missed, even by TC 176 itself it seems to me, is that AQAP-1, BS 5750 and ISO 9001 have only ever been litanies of 200+ checkpoints that a wise purchaser uses to assess the competency of a supplier.  ISO 9001 has never been particularly useful as a template for a full QA system, after all it only deals with the customer interface, it doesn't address the owner and staff expectations that underpin reality.  BS 4891 made this very clear in 1981.  In fact, see if you can find a copy of BSI Handbook 22 that first appeared in 1981.  The third edition is ISBN 0 580 16191 0 – compulsory reading if you want to understand where the quality management system thing came from.

So, with respect to this article, it is only TC-176 that has reached 25, ISO 9001 was nearly 20 years old when they started. And so far as I can see, their contribution has been less than impressive as they continue to miss the BIG PROBLEM - lousy implementation caused by misrepresentation of what ISO 9000 is REALLY about.

Having said all this, I do agree that ISO 9000 has changed the world - trouble is that it could have been so much better, what a pity Dr Deming wasn't discovered in the West until the formation stage was nearly all over.

Cheers

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